FDA Orange Book
Is there a generic for Wainua (autoinjector)?
Wainua (autoinjector) contains eplontersen. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Wainua (autoinjector) (eplontersen). The Orange Book shows its last listed patent expires August 25, 2034 and its last listed exclusivity ends December 21, 2030.
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Wainua (autoinjector) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) | Marketed (Rx) | None | 0 | None |
NDA 217388, held by ASTRAZENECA AB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Wainua (autoinjector) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8101743 | April 1, 2026 | Drug substance, Drug product | None | 217388 |
| 9127276 | May 1, 2034 | Drug substance | None | 217388 |
| 9181549 | May 1, 2034 | Drug substance | None | 217388 |
| 10683499 | August 25, 2034 | Drug substance, Drug product | U-2378 | 217388 |
Wainua (autoinjector) exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 21, 2028 | 217388 |
| ODE-461 | Orphan drug exclusivity | December 21, 2030 | 217388 |
Wainua (autoinjector) NDC codes
Questions
Is there a generic for Wainua (autoinjector)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Wainua (autoinjector) (eplontersen). The Orange Book shows its last listed patent expires August 25, 2034 and its last listed exclusivity ends December 21, 2030.
What is the generic name for Wainua (autoinjector)?
The active ingredient in Wainua (autoinjector) is eplontersen, per the FDA Orange Book.
When does the Wainua (autoinjector) patent expire?
The last patent listed for Wainua (autoinjector) in the Orange Book expires August 25, 2034. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.